Mental Health IssueNCT04873518
3D-Transition: Challenges and Resources of Children and Their Families During the Transition From Preschool to School
An observational study of Mental Health Issue and Externalizing Behavior Problems, run by St. Justine's Hospital at 3 sites in Canada.
Trial summary
The 3D-Transition study is a follow-up of the 3D Cohort pregnancy study (NCT03113331, which covered from the 1st trimester of pregnancy to age 2 years) as the children transition into kindergarten and first grade. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Externalizing Behavior Problems, Internalizing Behavior Problems
- How many people
- 939 participants
- Where
- 3 sitesCanada
- Study dates
- 1 May 2017to 21 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: General population sample from the main university hospitals affiliated with the province of Québec, Canada's 4 faculties of medicine between November 2010 and March 2013, included.
Who may be able to join
- All participating families from Clinical Trials NCT03113331 who had accepted a follow-up past the original pregnancy to age 2-years time span of that protocol.
Who cannot join
- None for this follow up. See Clinical Trials NCT03113331 for original exclusion criteria.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
CHU Ste-Justine Research Center
Montreal, Quebec, H3T 1C5
CHU de Quebec-Universite Laval
Québec, Quebec, G1V 4G2
Université de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: 3D-Transition Study: Challenges and Resources of Children and Their Families During the Transition From Preschool to School, in a Pregnancy Cohort
The 3D-Transition study is a follow-up of the 3D Cohort pregnancy study (NCT03113331, which covered from the 1st trimester of pregnancy to age 2 years) as the children transition into kindergarten and first grade. It aims at clarifying prenatal and preschool predictors of challenging and successful transitions to school as measured by mental health and academic outcomes.
Read the detailed description
Broad goal: This study seeks to understand how early vulnerabilities (externalizing or internalizing symptoms, or low neurodevelopmental/academic skills) turn into a rate of 10-15% of externalizing and internalizing mental health problems in school-aged children.
Rationale: Several lines of research guide this study. Functional impairments emerge for some children challenged by the transition to kindergarten and grade school. This risk is also thought to be programmed very early in life through cumulative early perinatal and psychosocial adversity. Further, interactions between the child, family and school environment during the transition may mitigate future impairments and this may be different for boys and girls. Finally, stress regulation mechanisms during the transition seem linked to early child vulnerabilities. This design allows us to contrast any combination of these mechanisms.
Aims: This study will clarify the role of:
- a mismatch between some child preschool vulnerability (externalizing, or internalizing symptoms, or low neurodevelopmental/academic skills) and the challenges of the transition from preschool to formal schooling;
- the experience of perinatal adversity and home chaos during child first years;
- supportive environments (high quality families or schools) during the school transition, and child sex; and
- the child stress response to the school transition, as assessed through salivary cortisol.
Method: Building on an existing pregnancy cohort (NCT03113331, which was structured around a triadic (mother-partner-child) framework, and which covered from the 1st trimester of pregnancy to age 2 years), the investigators have followed at least once 939 of 1551 families that agreed to a further follow-up past the initial study. Children in this cohort, who were seen in 3 waves based on age on September 30th, entered kindergarten in the fall of 2016, 2017, and 2018, respectively. A cohort-sequential longitudinal research design spanning pre-kindergarten to 2nd grade (ages 4 to 8 years), was implemented to follow each wave 6 times over 4 years. Cascade models will be used to address aims 1-3. The stress hormone cortisol will be examined on 11 days spread over a 16 months period for a subsample of 384 children to address aim 4, using growth curves models. This design is well suited and sufficiently powered to examine change processes over time, controlling for potential differences in waves and time of measurement effects.
Additional data: The Research Ethics Committee authorized two Corona Virus (COVID-19) supplemental data collections without additional consent for the spring of 2020 and the spring of 2021. However, cohorts 1 and 2, which had completed participation in 2019 and 2020, were re-consented, and this extended the maximum age range to 10 and 9 years, respectively. As of 2022-05-03 investigators are in the process of requesting approval for an additional COVID-19 follow-up.
Expected outcomes: Public health interventions are being put in place to help children manage the transition to school on the basis of little evidence. This longitudinal research will provide a greater understanding of individual and environmental factors linked to children's adaptation during the perinatal period and transitions to school. As such, mental health prevention research will be better informed on the developmental timing of individual and environmental targets that need to be considered in a developmental framework.
- Conditions
- Mental Health Issue, Externalizing Behavior Problems, Internalizing Behavior Problems, Cognitive Development, Neurodevelopmental Disorders, Academic Achievement
- Keywords
- longitudinal, cohort-sequential
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | These are the eldest children who entered kindergarten in September 2016. | |
| Cohort 2 | These children entered kindergarten in September 2017. | |
| Cohort 3 | These are the youngest children who entered kindergarten in September 2018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health: Change in child mental health represented by one latent symptom score of the overarching category: externalizing symptoms.
The latent factor will be based on three informants which provide these mental health symptom ratings: mother-, father-, and teacher-reports as measured with age-appropriate non-overlapping items from the externalizing symptoms scales of:
- the Strengths and Difficulties Questionnaire (SDQ) ii) the Child Behavior Checklist (CBCL) iii) the Behavior scale of the Quebec Longitudinal Study of Child Development (QLSCD).
Measured: Six times across 4 years, in the spring during Pre-Kindergarten, then in the fall and spring of Kindergarten and Grade 1, then in the spring of Grade 2
Mental health: Change in child mental health represented by one latent symptom score of the overarching category: internalizing symptoms.
The latent factor will be based on three informants which provide these mental health symptom ratings: mother-, father-, and teacher-reports as measured with age-appropriate non-overlapping items from the externalizing symptoms scales of:
- the Strengths and Difficulties Questionnaire (SDQ) ii) the Child Behavior Checklist (CBCL) iii) the Behavior scale of the Quebec Longitudinal Study of Child Development (QLSCD).
Measured: Six times across 4 years, in the spring during Pre-Kindergarten, then in the fall and spring of Kindergarten and Grade 1, then in the spring of Grade 2
Neurodevelopment - Change in executive function
Change in one latent factor score of executive function based on the following tasks:
- Dimensional Change Card Sort (DCCS) measuring degree of cognitive flexibility
- Random Object Span Task (ROST), a child version of the Self-Ordered Pointing (SOP) test measuring degree of working memory.
- Wechsler's Digit Span subtest measuring degree of working memory.
Measured: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Neurodevelopment - Change in visuo-spatial ability
Change in visuo-spatial ability based on the Wechsler's Block Design subtest.
Measured: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Neurodevelopment - Change in visuo-motor integration
Change on the Beery Visuo-Motor integration subtest.
Measured: Yearly, across 2 years: in Pre-Kindergarten and in Kindergarten
Neurodevelopment - Change in social cognition
Change in social cognition based on a latent factor of 1st and 2nd order Theory Of Mind (TOM) tests.
Measured: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Neurodevelopment - Change in emotional development
Change on the Pons and Harris (2000) Test of Emotion Comprehension (TEC) score.
Measured: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Academic skills scores - Change in school readiness
Change in the total score of The Lollipop Test comprising 4 dimensions: 1) Identification of Colors and Shapes, and Copying Shapes, 2) Picture Description, Position, and Spatial Recognition, 3) Identification of Numbers, and Counting, and 4) Identification of Letters, and Writing.
Measured: Yearly, across 2 years: in Pre-Kindergarten and Kindergarten
Academic skills scores- Change in Number Knowledge abilities
Change in a score combining The Number Knowledge Test (NKT) and the Mathematics subtest of the Canadian Achievement Test (CAT).
Measured: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Academic skills scores - Change in receptive vocabulary
Change in the total score of the Peabody Picture Vocabulary Test (PPVT) in French or English versions.
Measured: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Academic skills scores - Change in Reading ability
The Kaufman Assessment Battery for Children (K-ABC) reading ability test score in French or English versions.
Measured: Grade 1 only
Academic skills scores - Change in academic performance.
Change in teacher reports on child academic achievement.
Measured: Yearly, across 2 years: in Grades 1 and 2
Change in Morning and evening salivary cortisol levels
A subsample of 382 (out of 400 targeted) from cohorts 2 and 3 participated in a measurement burst design of 11 measurement days (2 samples/day), in June and August preceding entry into kindergarten (baseline), then twice one week apart at kindergarten entry in early September, then first Wednesday in each of November, February, and April. The following June, August, and early September measures were then repeated as the children moved towards entry to 1st grade.
Measured: Pre-Kindergarten to Grade 1 (Across a 16 months period from June in Year 1 to September in Year 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 May 2017
- Primary completion21 Dec 2022 (estimated)
- Study completion21 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 939 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Université de Sherbrooke, CHU de Quebec-Universite Laval, Université de Montréal, Laval University
- Responsible party
- Principal investigator, Jean Séguin, St. Justine's Hospital
- Investigators
- Jean R. Séguin, Ph.D., Principal investigator, CHU Ste-Justine Research Center and Université de MontréalSophie Parent, Ph.D., Principal investigator, CHU Ste-Justine Research Center and Université de MontréalNatalie Castellanos-Ryan, Ph.D., Principal investigator, CHU Ste-Justine Research Center and Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873518
- Sponsor's protocol ID
- MP-21-2017-1461
- Other IDs
- PJT-148551, PJT-165824, CRI-88413
- Status last verified
- May 2022
- First submitted
- 13 Apr 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures by which de-identified data will be accessible are being clarified as rules and regulations are currently under study in this jurisdiction. In the meantime the investigators can be contacted for updates - see "More information"
Publications
Parent S, Lupien S, Herba CM, Dupere V, Gunnar MR, Seguin JR. Children's cortisol response to the transition from preschool to formal schooling: A review. Psychoneuroendocrinology. 2019 Jan;99:196-205. doi: 10.1016/j.psyneuen.2018.09.013. Epub 2018 Sep 14.
PubMed 30253327Rioux C, Parent S, Castellanos-Ryan N, Archambault I, Boivin M, Herba CM, Lupien SJ, Marc I, Muckle G, Fraser WD, Seguin JR. The 3D-Transition Study: Objectives, Methods, and Implementation of an Innovative Planned Missing-Data Design. Am J Epidemiol. 2021 Nov 2;190(11):2262-2274. doi: 10.1093/aje/kwab141.
PubMed 33987638Leblond M, Parent S, Castellanos-Ryan N, Lupien SJ, Fraser WD, Seguin JR. Transition from preschool to school: Children's pattern of change in morning cortisol concentrations. Psychoneuroendocrinology. 2022 Jun;140:105724. doi: 10.1016/j.psyneuen.2022.105724. Epub 2022 Mar 14.
PubMed 35325645
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-Transition Study: Challenges and Resources of Children and Their Families During the Transition From Preschool to School, in a Pregnancy Cohort
- ClinicalTrials.gov ID
- NCT04873518
- Acronym / sponsor ID
- MP-21-2017-1461
- Conditions
- Mental Health Issue, Externalizing Behavior Problems, Internalizing Behavior Problems, Cognitive Development, Neurodevelopmental Disorders, Academic Achievement
- Keywords
- longitudinal, cohort-sequential
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 939 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Université de Sherbrooke, CHU de Quebec-Universite Laval, Université de Montréal, Laval University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 21 Dec 2022 (estimated)
- Study completion
- 21 Dec 2022 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 3D-Transition study is a follow-up of the 3D Cohort pregnancy study (NCT03113331, which covered from the 1st trimester of pregnancy to age 2 years) as the children transition into kindergarten and first grade. It aims at clarifying prenatal and preschool predictors of challenging and successful transitions to school as measured by mental health and academic outcomes.
Detailed description
Broad goal: This study seeks to understand how early vulnerabilities (externalizing or internalizing symptoms, or low neurodevelopmental/academic skills) turn into a rate of 10-15% of externalizing and internalizing mental health problems in school-aged children.
Rationale: Several lines of research guide this study. Functional impairments emerge for some children challenged by the transition to kindergarten and grade school. This risk is also thought to be programmed very early in life through cumulative early perinatal and psychosocial adversity. Further, interactions between the child, family and school environment during the transition may mitigate future impairments and this may be different for boys and girls. Finally, stress regulation mechanisms during the transition seem linked to early child vulnerabilities. This design allows us to contrast any combination of these mechanisms.
Aims: This study will clarify the role of:
- a mismatch between some child preschool vulnerability (externalizing, or internalizing symptoms, or low neurodevelopmental/academic skills) and the challenges of the transition from preschool to formal schooling;
- the experience of perinatal adversity and home chaos during child first years;
- supportive environments (high quality families or schools) during the school transition, and child sex; and
- the child stress response to the school transition, as assessed through salivary cortisol.
Method: Building on an existing pregnancy cohort (NCT03113331, which was structured around a triadic (mother-partner-child) framework, and which covered from the 1st trimester of pregnancy to age 2 years), the investigators have followed at least once 939 of 1551 families that agreed to a further follow-up past the initial study. Children in this cohort, who were seen in 3 waves based on age on September 30th, entered kindergarten in the fall of 2016, 2017, and 2018, respectively. A cohort-sequential longitudinal research design spanning pre-kindergarten to 2nd grade (ages 4 to 8 years), was implemented to follow each wave 6 times over 4 years. Cascade models will be used to address aims 1-3. The stress hormone cortisol will be examined on 11 days spread over a 16 months period for a subsample of 384 children to address aim 4, using growth curves models. This design is well suited and sufficiently powered to examine change processes over time, controlling for potential differences in waves and time of measurement effects.
Additional data: The Research Ethics Committee authorized two Corona Virus (COVID-19) supplemental data collections without additional consent for the spring of 2020 and the spring of 2021. However, cohorts 1 and 2, which had completed participation in 2019 and 2020, were re-consented, and this extended the maximum age range to 10 and 9 years, respectively. As of 2022-05-03 investigators are in the process of requesting approval for an additional COVID-19 follow-up.
Expected outcomes: Public health interventions are being put in place to help children manage the transition to school on the basis of little evidence. This longitudinal research will provide a greater understanding of individual and environmental factors linked to children's adaptation during the perinatal period and transitions to school. As such, mental health prevention research will be better informed on the developmental timing of individual and environmental targets that need to be considered in a developmental framework.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –These are the eldest children who entered kindergarten in September 2016. |
| Cohort 2 | – | –These children entered kindergarten in September 2017. |
| Cohort 3 | – | –These are the youngest children who entered kindergarten in September 2018 |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- General population sample from the main university hospitals affiliated with the province of Québec, Canada's 4 faculties of medicine between November 2010 and March 2013, included.
Key inclusion criteria (1 listed)
- All participating families from Clinical Trials NCT03113331 who had accepted a follow-up past the original pregnancy to age 2-years time span of that protocol.
Key exclusion criteria (1 listed)
- None for this follow up. See Clinical Trials NCT03113331 for original exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mental health: Change in child mental health represented by one latent symptom score of the overarching category: externalizing symptoms.
Time frame: Six times across 4 years, in the spring during Pre-Kindergarten, then in the fall and spring of Kindergarten and Grade 1, then in the spring of Grade 2
The latent factor will be based on three informants which provide these mental health symptom ratings: mother-, father-, and teacher-reports as measured with age-appropriate non-overlapping items from the externalizing symptoms scales of: i) the Strengths and Difficulties Questionnaire (SDQ) ii) the Child Behavior Checklist (CBCL) iii) the Behavior scale of the Quebec Longitudinal Study of Child Development (QLSCD).
Mental health: Change in child mental health represented by one latent symptom score of the overarching category: internalizing symptoms.
Time frame: Six times across 4 years, in the spring during Pre-Kindergarten, then in the fall and spring of Kindergarten and Grade 1, then in the spring of Grade 2
The latent factor will be based on three informants which provide these mental health symptom ratings: mother-, father-, and teacher-reports as measured with age-appropriate non-overlapping items from the externalizing symptoms scales of: i) the Strengths and Difficulties Questionnaire (SDQ) ii) the Child Behavior Checklist (CBCL) iii) the Behavior scale of the Quebec Longitudinal Study of Child Development (QLSCD).
Neurodevelopment - Change in executive function
Time frame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Change in one latent factor score of executive function based on the following tasks: 1. Dimensional Change Card Sort (DCCS) measuring degree of cognitive flexibility 2. Random Object Span Task (ROST), a child version of the Self-Ordered Pointing (SOP) test measuring degree of working memory. 3. Wechsler's Digit Span subtest measuring degree of working memory.
Neurodevelopment - Change in visuo-spatial ability
Time frame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Change in visuo-spatial ability based on the Wechsler's Block Design subtest.
Neurodevelopment - Change in visuo-motor integration
Time frame: Yearly, across 2 years: in Pre-Kindergarten and in Kindergarten
Change on the Beery Visuo-Motor integration subtest.
Neurodevelopment - Change in social cognition
Time frame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Change in social cognition based on a latent factor of 1st and 2nd order Theory Of Mind (TOM) tests.
Neurodevelopment - Change in emotional development
Time frame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Change on the Pons and Harris (2000) Test of Emotion Comprehension (TEC) score.
Academic skills scores - Change in school readiness
Time frame: Yearly, across 2 years: in Pre-Kindergarten and Kindergarten
Change in the total score of The Lollipop Test comprising 4 dimensions: 1) Identification of Colors and Shapes, and Copying Shapes, 2) Picture Description, Position, and Spatial Recognition, 3) Identification of Numbers, and Counting, and 4) Identification of Letters, and Writing.
Academic skills scores- Change in Number Knowledge abilities
Time frame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Change in a score combining The Number Knowledge Test (NKT) and the Mathematics subtest of the Canadian Achievement Test (CAT).
Academic skills scores - Change in receptive vocabulary
Time frame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Change in the total score of the Peabody Picture Vocabulary Test (PPVT) in French or English versions.
Academic skills scores - Change in Reading ability
Time frame: Grade 1 only
The Kaufman Assessment Battery for Children (K-ABC) reading ability test score in French or English versions.
Academic skills scores - Change in academic performance.
Time frame: Yearly, across 2 years: in Grades 1 and 2
Change in teacher reports on child academic achievement.
Change in Morning and evening salivary cortisol levels
Time frame: Pre-Kindergarten to Grade 1 (Across a 16 months period from June in Year 1 to September in Year 2)
A subsample of 382 (out of 400 targeted) from cohorts 2 and 3 participated in a measurement burst design of 11 measurement days (2 samples/day), in June and August preceding entry into kindergarten (baseline), then twice one week apart at kindergarten entry in early September, then first Wednesday in each of November, February, and April. The following June, August, and early September measures were then repeated as the children moved towards entry to 1st grade.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Background: PubMed 30253327Parent S, Lupien S, Herba CM, Dupere V, Gunnar MR, Seguin JR. Children's cortisol response to the transition from preschool to formal schooling: A review. Psychoneuroendocrinology. 2019 Jan;99:196-205. doi: 10.1016/j.psyneuen.2018.09.013. Epub 2018 Sep 14.
- Background: PubMed 33987638Rioux C, Parent S, Castellanos-Ryan N, Archambault I, Boivin M, Herba CM, Lupien SJ, Marc I, Muckle G, Fraser WD, Seguin JR. The 3D-Transition Study: Objectives, Methods, and Implementation of an Innovative Planned Missing-Data Design. Am J Epidemiol. 2021 Nov 2;190(11):2262-2274. doi: 10.1093/aje/kwab141.
- Results publication: PubMed 35325645Leblond M, Parent S, Castellanos-Ryan N, Lupien SJ, Fraser WD, Seguin JR. Transition from preschool to school: Children's pattern of change in morning cortisol concentrations. Psychoneuroendocrinology. 2022 Jun;140:105724. doi: 10.1016/j.psyneuen.2022.105724. Epub 2022 Mar 14.
- Individual participant dataSharing planned: Yes. The procedures by which de-identified data will be accessible are being clarified as rules and regulations are currently under study in this jurisdiction. In the meantime the investigators can be contacted for updates - see "More information"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean R. Séguin, Ph.D. principal investigator
CHU Ste-Justine Research Center and Université de Montréal
Sophie Parent, Ph.D. principal investigator
CHU Ste-Justine Research Center and Université de Montréal
Natalie Castellanos-Ryan, Ph.D. principal investigator
CHU Ste-Justine Research Center and Université de Montréal
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue and Externalizing Behavior Problems, run by St. Justine's Hospital at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health: Change in child mental health represented by one latent symptom score of the overarching category: externalizing symptoms. (time frame: Six times across 4 years, in the spring during Pre-Kindergarten, then in the fall and spring of Kindergarten and Grade 1, then in the spring of Grade 2). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04873518, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.